Surgical procedure and related apparatus for treating sleep apnea by lifting, suspending and stiffening the soft palate

ABSTRACT

Methods and apparatuses for lifting, suspending and stiffening a patient&#39;s tissue are disclosed. In an embodiment, a method of lifting and stiffening a patient&#39;s tissue includes inserting at least one suture into the patient&#39;s tissue in a first direction, pulling the suture in a second direction so as to lift and suspend the tissue in a lifted position and stiffen the tissue in the lifted position, and cutting the suture so that the tissue remains in the lifted position. Preferably, the patient&#39;s tissue is the patient&#39;s soft palate.

FIELD OF THE INVENTION

The present disclosure relates generally to methods and apparatuses forlifting, suspending and stiffening a patient's tissue, and morespecifically to treating sleep apnea by lifting, suspending andstiffening a patient's soft palate and/or uvula.

BACKGROUND

Snoring affects approximately 50% of men and 30% of women and iscommonly caused by the oscillation of the uvula, the free edges of thesoft palate (also known as the velum or muscular plate) and the faucialpillars. Chronic snorers often report restless sleep, morning headachesand excessive fatigue. Other common findings are memory andconcentration difficulties, behavioral changes including irritability,impotence and loss of alertness, and even sudden death from accidents orcardiovascular complications.

Snoring is a precursor to obstructive sleep apnea syndrome (OSA), andcan be a risk factor for hypertension, cardiac arrhythmias, anginapectoris, cerebral infarction, pulmonary hypertension and congestiveheart failure, all of which are commonly associated with OSA. OSA is themost common type of sleep apnea and results from the collapse of thepharyngeal wall in response to negative inspiratory pressure in theupper airway. Hypotonicity of the pharyngeal musculature allows theupper airway to collapse even at the most modest negative inspiratorypressures, leading to snoring or apnea. The collapse occurs when thenegative pressure within the pharynx exceeds the ability of its wallsand musculature to maintain a patient airway. Any narrowing along theupper airway will increase the pressure and subsequently promote furthernarrowing or will require an increase in the velocity of airflow,further reducing intraluminal pressure.

A redundant palate or elongated or thick uvula can also cause snoringfrom the rapid airflow created by inspiratory pressure. Further anatomicnarrowing or obstruction anywhere along the upper airway can cause OSA.Other causes of physiologic dysfunction of neuromuscular and respiratorycontrol mechanisms can also cause OSA.

Various methods have been developed to treat snoring and OSA.Uvulopalatopharyngoplasty (UPPP) was first designed as a surgicaltreatment for snoring and was later applied to OSA. UPPP is performed byremoving the anterior surface of the soft palate and uvula and suturingthe uvula to the soft palate. There are, however, risks associated withUPPP such as causing excess scar tissue to tighten the airway andactually making the airway smaller than before UPPP.

Laser assisted uvulopalatoplasty (LAUP) was developed as an alternativeto UPPP to treat OSA. LAUP is performed by using a laser, typically aCO₂ laser, to remove parts of the uvula. LAUP also has its risks, as thescar tissue from the laser can reduce the airspace in the pharynx,leading to velopharyngeal insufficiency. The scar tissue can also makethe airway more prone to collapse during sleep.

Several other procedures have also been developed to treat OSA. Forexample, somnoplasty uses radiofrequncy ablation to cause coagulationnecrosis (clotting) in the tissue in a patient's mouth. Pillar implantscan be inserted into a patient's soft palate to cause the palate tostiffen. Sclerotherapy uses a medicinal injection to shrink bloodvessels. Each of these alterative procedures also has associateddisadvantages. For example, these alternative procedures do not allow adoctor to lift and suspend the soft palate. These procedures are alsopermanent, that is, once the tissue is removed, it cannot be replaced.

SUMMARY

The present disclosure provides methods and apparatuses for lifting,suspending and stiffening a patient's tissue, specifically a patient'ssoft palate and/or uvula. In an example embodiment, a method of liftingand stiffening a patient's tissue includes inserting at least one sutureinto the patient's tissue in a first direction, pulling the suture in asecond direction so as to lift and suspend the tissue in a liftedposition and stiffen the tissue in the lifted position, and cutting thesuture so that the tissue remains in the lifted position.

In another example embodiment, a method of lifting and stiffening apatient's tissue includes loading a suture onto a piercing shaft of asuture insertion device, inserting the piercing shaft into the patient'stissue in a first direction, releasing the suture from the piercingshaft, withdrawing the piercing shaft from the patient's tissue, andpulling the suture in a second direction so as to lift, suspend andstiffen the tissue.

In another example embodiment, a suture insertion device, includes abody and a piercing shaft connected to the body, the piercing shaftincluding a piercing end, the piercing shaft configured to pierce apatient's tissue with the piercing end and insert a suture into thepatient's tissue in a first direction, wherein the piercing shaft isfurther configured to release the suture into the patient's tissue suchthat the suture can be pulled in a second direction to lift, suspend andstiffen the patient's tissue once the piercing shaft is removed from thepatient's tissue.

In another example embodiment, a suture insertion device, includes ameans for loading a suture, a means for inserting the suture into apatient's tissue in a first direction, and a means for releasing thesuture so that the suture can be pulled in a second direction differentfrom the first direction so as to lift, suspend and stiffen the tissue.

In another example embodiment, a suture insertion device includes abody, a piercing shaft connected to the body, the piercing shaftincluding a cannula and a threading notch configured to receive asuture, and an insertion shaft moveable within the cannula, theinsertion shaft configured to release the suture from the piercingshaft.

In another example embodiment, a suture insertion device includes abody, a piercing shaft connected to the body, the piercing shaftincluding a threading notch configured to receive a suture, and a clampconfigured to clamp the suture to the body when the piercing shaft isinserted into a patient's tissue and to release the suture from the bodywhen the piercing shaft is withdrawn from the patient's tissue.

BRIEF DESCRIPTION OF THE FIGURES

Embodiments of the present disclosure will now be explained in furtherdetail by way of example only with reference to the accompanyingfigures, in which:

FIG. 1 is a front view of an example mouth of a snoring patient;

FIG. 2 is a front view comparing an example mouth of a non-snoringpatient to the mouth of FIG. 1;

FIG. 3 is a front view of an example mouth of a snoring patient;

FIG. 4 is a side view illustrating an example method according to thepresent disclosure;

FIG. 5 is a side view illustrating an example method according to thepresent disclosure;

FIG. 6 shows the Ikematsu System for the Diagnosis of Snoring;

FIG. 7 is a side view of an example embodiment of a suture insertiondevice according to the present disclosure;

FIG. 8 is a side view of the device of FIG. 7 being inserted into apatient's soft palate;

FIG. 9 is a side view of the device of FIG. 7 being inserted into apatient's soft palate;

FIG. 10 is a side view of the device of FIG. 7 being removed from apatient's soft palate;

FIG. 11 is a side view of the device of FIG. 7 being removed from apatient's soft palate;

FIG. 12 is a side view of the device of FIG. 7 being removed from apatient's soft palate;

FIG. 13 is a side view of an example patient that has been treated withthe device of FIG. 7;

FIG. 14 is a front view of an example patient that has been treated withthe device of FIG. 7;

FIG. 15 is a side view of an example embodiment of a suture insertiondevice according to the present disclosure;

FIG. 16 is a side view of the device of FIG. 14;

FIG. 17 is a detailed view from FIG. 16;

FIG. 18 is a side view of the device of FIG. 14;

FIG. 19 is a detailed view from FIG. 18;

FIG. 20 is a side view of the device of FIG. 14;

FIG. 21 is a detailed view from FIG. 20;

FIG. 22 is a side view of the device of FIG. 14 being inserted into apatient's soft palate;

FIG. 23 is a side view of the device of FIG. 14 being inserted into apatient's soft palate;

FIG. 24 is a side view of the device of FIG. 14 being removed from apatient's soft palate;

FIG. 25 is a side view of the device of FIG. 14 being removed from apatient's soft palate;

FIG. 26 is a side view of an example embodiment of a suture insertiondevice according to the present disclosure;

FIG. 27 is a detailed view from FIG. 26;

FIG. 28 is a cross-sectional view taken across lines 28-28 in FIG. 27;

FIG. 29 is a side view of the device of FIG. 26 being inserted into apatient's soft palate;

FIG. 30 is a side view of the device of FIG. 26 being removed from apatient's soft palate;

FIG. 31 is a side view of an example embodiment of a suture insertiondevice according to the present disclosure;

FIG. 32 is a side view of the device of FIG. 31;

FIG. 33 is a side view illustrating a method of receiving a suture onthe device of FIG. 31;

FIG. 34 is a side view illustrating a method of receiving a suture onthe device of FIG. 31;

FIG. 35 is a side view illustrating a method of receiving a suture onthe device of FIG. 31;

FIG. 36 is a side view illustrating a method of receiving a suture onthe device of FIG. 31;

FIG. 37 is a side view illustrating a method of receiving a suture onthe device of FIG. 31;

FIG. 38 is a side view illustrating a method of receiving a suture onthe device of FIG. 31;

FIG. 39 is a side view of an example embodiment of a suture insertiondevice according to the present disclosure;

FIG. 40 is a side view illustrating a method of receiving a suture onthe device of FIG. 39;

FIG. 41 is a side view illustrating a method of receiving a suture onthe device of FIG. 39; and

FIG. 42 is a side view illustrating a method of receiving a suture onthe device of FIG. 39.

DETAILED DESCRIPTION

FIG. 1 illustrates an example mouth 1 of a typical snoring patient. FIG.2 compares the mouth 1 of the snoring patient in FIG. 1 to an examplemouth 11 of a non-snoring patient. The snoring patient's mouth 1 has ahigher tongue base 2, an enlarged uvula 4, a long, low, thick palate 6,a large tonsil 8 and a vertical pharyngeal fold 10. In comparison, thenon-snoring patient's mouth 11 has a lower tongue base 12, a smaller,higher uvula 14, a high, thin palate 16, a small tonsil 18 and novertical pharyngeal fold. These differences between the snorer's mouth 1and the non-snorer's mouth 11 can cause the snorer's upper airway tobecome obstructed.

The present disclosure seeks to correct at least the large uvula 4and/or the thick palate 6 of the snoring patient's mouth 1 by providinga method and apparatus for an office-based treatment of a patient's softpalate and/or uvula to correct sleep apnea as well as symptomatic,habitual and social snoring due to palatial flutter. In an exampleembodiment, a method of lifting, suspending and stiffening a patient'ssoft palate includes inserting one or more barbed sutures into thepatient's soft palate to suspend and stiffen the soft palate. Thepatient's soft palate can be lifted, suspended and stiffened by pullingthe soft palate and/or uvula in a direction different from the insertiondirection of the suture and suspending the soft palate and/or uvula inthat position.

In an example embodiment, the present method begins by applying a localanesthesia to a patient's soft palate. Preferably, 2 cubic centimetersof 2% lidocaine with 1:100,000 epinephrine is injected at threedifferent points 20 in the patient's soft palate 22, above the uvula 24and near the location where one or more sutures will be inserted intothe soft palate, as shown in FIG. 3. The injection should be slow andintramuscular and can take effect within minutes.

Once the patient has been anesthetized, one or more sutures can beinserted into the patient's soft palate 22 by locating the midline 26between the patient's hard palate 28 and soft palate 22 and insertingthe one or more sutures 36 into the patient's soft palate as close tothe junction of the soft 22 and hard 28 palates as possible. The sutures36 can be inserted using a needle 30 or another suture insertion device,such as the suture insertion devices described in more detail below. Inan example embodiment, the sutures 36 are inserted with a needle 30 byinserting the needle 30 into the patient's soft palate 22 so that theneedle 30 extends into the soft palate 22 and optionally also into theuvula 24. As illustrated in FIG. 4, the needle can be inserted into thesoft palate 22 so that the piercing end 32 of the needle 30 extends toalmost the tip 29 of the uvula 24. The needle 30 can optionally includedepth markings so that the doctor performing the procedure canaccurately determine how far the suture 36 has been inserted into thepatient's soft palate 24. The needle 30 preferably includes a curvedpiercing end 34 shaped to approximately mirror the natural curve of thepatient's soft palate 22 and uvula 24. In an example embodiment, theneedle 30 is a straight needle with an 18 mm straight portion and acurved portion with a 20 mm radius. In another example embodiment, theneedle 30 is a semi-curved needle with a 9 mm straight portion and acurved portion with a 27 mm radius. In another example embodiment, theneedle is a curved needle with a curved portion with a 38 mm radius.Those of ordinary skill in the art will understand that the length ofthe needle 30 will vary according to the anatomic site.

The suture 36 is preferably a barbed suture that includes barbs 38extending from the suture in a direction opposite to the direction ofinsertion of the suture. Such barbs 38 allow the suture 36 to lift,suspend and stiffen a patient's soft palate 22 and uvula 24 by grabbingthe soft palate 22 and uvula 24 with the barbs 38 and allowing thedoctor to pull the soft palate and/or uvula in a direction opposite ordifferent from the insertion direction of the suture 36. In an exampleembodiment, the suture 36 can include bidirectional barbs. The barbs 38eliminate the need to tie knots in the suture 36 because the barbs 38can grab the tissue of the soft palate 22 and/or uvula 24 and distributetension across the entire length of the tissue, which allows the softpalate 22 and/or uvula 24 to be lifted, suspended and stiffened bypulling the suture in an opposite or different direction from thedirection of insertion once the suture has been inserted into thepatient. One suitable suture is the Quill Knotless Tissue-Closure Devicemanufactured by Angiotech Pharmaceuticals, Inc. of Vancouver, Canada. Inan example embodiment, size 0, 1 or 2 sutures can be used depending onthe patient. In an example embodiment, the suture 36 can be pre-twistedand/or barbed in different directions and/or can include one or moreknots and/or loops at an end. In an example embodiment, the centerportion of the suture 36 is clear when the center portion is the firstportion to enter the patient's soft palate 22. That is, the centerportion of the suture 36 does not include barbs 38, which allows thecenter portion of the suture to be easily inserted into the soft palate22 by folding the suture through the needle 30 or suture insertiondevice and causing the center portion of the suture to be the firstportion of the suture inserted into the patient's soft palate. Inanother example embodiment, the suture 36 is dissolvable, preferablywithin three months. Preferably, the suture dissolves in a time periodsufficient to allow the soft palate 22 to permanently suspend andstiffen the patient's soft palate 22 and/or uvula 24. Non-dissolvablesutures and sutures that dissolve in more or less than three months canalso be used. An advantage of the present invention is that a doctorusing the disclosed methods and apparatuses can easily alter thetreatment type and suture type for patients with a wide variety ofconditions.

Once the suture 36 has been inserted into the patient's soft palate 22and preferably the patient's uvula 24, it can be pulled in a direction Dthat is different than the insertion direction, as shown in FIG. 5. Thepulling lifts the soft palate 22 and/or uvula 24 as the barbs of thesuture 36 grab the patient's soft palate and/or uvula and pull the softpalate and/or uvula in the direction D of the pulling. At the same time,the pulling also stiffens the soft palate 22 and/or uvula 24 bycompressing the soft palate and/or uvula into a smaller area. The barbs38 suspend the soft palate 22 and/or uvula 24 in the lifted andstiffened position once the doctor has appropriately positioned the softpalate and/or uvula. Proper placement of the suture can be verified bytugging and wiggling the suture.

In another example embodiment, the suture 36 can be inserted into thepatient's soft palate 22 and uvula 24 using a triangular approach,wherein the needle 30 is inserted into a first side of the patient'ssoft palate 22 at an angle so that it extends to the uvula and theneedle is then pushed at an angle through a second side of the softpalate 22 so that the suture 36 forms a triangle in the patient's softpalate 22 and uvula 24 and the suture 36 extends through the outersurface of the soft palate at both the first and second sides. When theneedle 30 is removed, the suture 36 can be pulled from one or both ofthe first and second sides of the soft palate 22. The pulling lifts thesoft palate 22 and/or uvula 24 as the barbs of the suture 36 grab thepatient's soft palate and/or uvula and pull the soft palate and/or uvulain the direction D of the pulling. At the same time, the pulling alsostiffens the soft palate 22 and/or uvula 24 by compressing the softpalate and/or uvula into a smaller area. The barbs 38 suspend the softpalate 22 and/or uvula 24 in the lifted and stiffened position once thedoctor has appropriately positioned the soft palate and/or uvula. Properplacement of the suture can be verified by tugging and wiggling thesuture.

The present method of lifting, suspending and stiffening the soft palatecan be titrated according to any anatomy. FIG. 6 illustrates theIkematsu System for the Diagnosis of Snoring. One problem with currenttreatments for sleep apnea is that one modality of treatment does notwork for all of the different uvula types shown in FIG. 6. The disclosedmethod can be tailored to each individual patient's specific needs. Adoctor can choose one or more sutures 36 and insert the suture orsutures in one or more different locations in the patient's soft palate22 and/or uvula 24 at one or more different angles. The disclosed methodallows the doctor to adjust the patient's soft palate 22 and/or uvula 24to an appropriate position as the treatment is being administered,giving the doctor freedom to treat each specific patient as needed.

FIG. 7 illustrates an example embodiment of a suture insertion device 50according to the present disclosure. In an example embodiment, sutureinsertion device 50 includes a handle 52, a piercing shaft 54 and asuture release button 56. Piercing shaft 54 includes a piercing end 58with a sharp tip which allows piercing shaft 54 to be inserted into apatient's soft palate 22. In an example embodiment, piercing shaft 54 isa cannula. Once inserted into the soft palate, a suture 36 can bereleased from piercing end 58 by pressing suture release button 56.Because piercing end 56 pierces the patient's skin, suture insertiondevice 50 is preferably a disposable, single-use device that can bediscarded after a single procedure so as not to spread infection amongstpatients.

FIGS. 8 to 14 demonstrate an example method of using suture insertiondevice 20 to lift and stiffen a patient's soft palate 22 and uvula 24 toopen the patient's airways. FIG. 8 shows a patient 19 with an elongateduvula 24. The midline 26 of the patient's soft palate 22 is located sothat piercing shaft 54 of suture insertion device 50 can be insertedinto the patient's soft palate 22 at or near the midline 26 of the softpalate 22. For different types of soft palates and uvulas, the piercingshaft 54 of suture insertion device 50 can be inserted into otherlocations in the soft palate at other angles.

FIG. 9 shows the piercing shaft 54 of suture insertion device 50 beinginserted into the patient's soft palate 22 at a high point at themidline 26 of the soft palate 22. The placement of suture insertiondevice 50 should be verified. In the illustrated embodiment, piercingshaft 54 of suture insertion device 50 is inserted into the soft palate22 so that the piercing end 58 extends to almost the tip 29 of the uvula24. The curve of piercing shaft 54 is designed to approximately matchthe curvature of the patient's soft palate 22. In other embodiments,piercing shaft 54 of suture insertion device 50 is inserted into thesoft palate 22 so that the piercing end 58 extends to differentlocations in the soft palate. Piercing shaft 54 can optionally includedepth markings so that the doctor performing the procedure canaccurately determine how far the piercing shaft 54 has been insertedinto the patient's soft palate 22. In an example embodiment, piercingshaft 54 includes an 18 mm straight portion and a curved portion with a20 mm radius. In another example embodiment, piercing shaft 54 includesa 9 mm straight portion and a curved portion with a 27 mm radius. Inanother example embodiment, piercing shaft 54 includes a curved portionwith a 38 mm radius. Those of ordinary skill in the art will understandthat the length and curvature of piercing shaft 54 will vary accordingto the anatomic site.

FIG. 10 shows the release of suture 36 from piercing shaft 54 of sutureinsertion device 50. Once piercing shaft 54 of suture insertion device50 has been appropriately positioned and the position has been verified,suture 36 can be released from piercing end 58 by pressing suturerelease button 56. As the suture 36 is released from piercing shaft 54,piercing shaft 54 is withdrawn from the patient's soft palate 22. Thebarbs 38 on suture 36 grab the patient's uvula 24 and/or soft palate 22and hold suture 36 in place as piercing shaft 54 is withdrawn. FIG. 11shows the release of a length 42 of suture 36 as the piercing shaft 54of suture insertion device 50 is completely withdrawn from the patient'ssoft palate 22. In one example embodiment, suture release button 56 canrelease suture 36 continuously. In another example embodiment, suturerelease button 56 can release suture 36 in discrete increments.

FIG. 11 shows the patient's soft palate 22 and uvula 24 being elevated.Once the piercing shaft 54 has been withdrawn from the patient's softpalate 22, suture release button 56 is released so that suture 36 ceasesto be released from piercing shaft 54. Once the suture 36 ceases to bereleased, suture insertion device 50 can be pulled in a directiondifferent than the insertion direction to elevate the patient's palate22 and raise the patient's uvula 24. The pulling lifts the soft palate22 and uvula 24 as the barbs 38 of the suture 36 grab the patient's softpalate and uvula and pull the soft palate and uvula in the direction ofthe pulling. The pulling also stiffens the soft palate 22 and uvula 24by compressing the soft palate and uvula into a smaller area. The barbs38 suspend the soft palate 22 and/or uvula 24 in the lifted andstiffened position once the doctor has appropriately positioned the softpalate and/or uvula. Proper placement of the suture can be verified bytugging and wiggling the suture. Once the patient's palate is accuratelypositioned, the suture 36 can be cut from piercing shaft 54 using acutting device 44. Cutting device 44 can be a scissors as shown in FIG.12, or it can be any other device separate from suture insertion device50 and capable of cutting suture 36. In an alternative embodiment,cutting device 44 can be part of suture insertion device 50 and can cutsuture 36 with, for example, the press of a button. Such an alternativeembodiment is advantageous in that it simplifies the process and reducesthe tooling. Using a separate cutting device is alternativelyadvantageous in that the suture insertion device 50 can be more cheaplymanufactured as a disposable single-use device which can be discardedafter a single procedure. Further alternatively, suture 36 can be cutfrom suture insertion device 50 before the patient's soft palate 22 hasbeen elevated and the patient's uvula 24 has been raised. A doctor canthen grab the suture with his or her hands to perform the lifting andstiffening described above.

The process can then be repeated with as many sutures 36 as necessary tolift, suspend and stiffen the patient's soft palate 22 and/or uvula 24.The sutures 36 can be inserted in different parts of the patient's softpalate 22 and/or uvula 24 and can be inserted at different angles. FIGS.13 and 14 show a side view and a front view, respectively, of an exampleembodiment of a patient's mouth once three sutures 36 have been placedin the patient's soft palate. In the example embodiment shown, the threesutures 36 have been inserted into the patient's soft palate 22 side byside at the midline 26 between the patient's hard palate 28 and softpalate 22. In another example embodiment, the suture 36 can be insertedinto the patient's soft palate 22 and uvula 24 using the triangularapproach described above, wherein the piercing shaft 54 is inserted intoa first side of the patient's soft palate 22 at an angle so that thepiercing shaft extends to the uvula and the piercing shaft 54 is thenpushed at an angle through a second side of the soft palate 22 so thatthe suture 36 forms a triangle in the patient's soft palate 22 and uvula24 and the suture 36 extends through the outer surface of the softpalate at both the first and second sides.

FIG. 15 illustrates another example embodiment of a suture insertiondevice 100 according to the present disclosure. In an exampleembodiment, suture insertion device 100 includes a main body 101, ahandle 102, a piercing shaft 104, a suture release button 106, aninsertion shaft 108 and an insertion shaft adjustment 110. Piercingshaft 104 includes a piercing end 112 with a sharp tip that allowspiercing shaft 104 to be inserted into a patient's soft palate 22. In anexample embodiment, piercing shaft 104 is a cannula and insertion shaft108 is moveable within the cannula. Once inserted into the soft palate22, insertion shaft 108 can be deployed from inside piercing shaft 104so as to deploy a length of a suture 36. Because piecing end 112 piercesa patient's skin, suture insertion device 100 is preferably adisposable, single-use device that can be discarded after a singleprocedure so as not to spread infection amongst patients.

FIGS. 16 to 22 demonstrate an example method of using suture insertiondevice 100 to lift and stiffen a patient's soft palate 22 and/or uvula24 to open the patient's airways. Preferably, suture insertion device100 is not preloaded with a suture. Instead, suture insertion device canbe loaded with any type of suture that a doctor chooses to best treat aspecific patient.

FIGS. 16 and 18 show cross-sectional views of suture insertion device100 in a first, loading configuration. In the first, loadingconfiguration, insertion shaft adjustment 110 is in a loading positionsuch that the end of insertion shaft 108 is located at a threading notch116 of suture insertion device 100. FIGS. 17 and 19 show a blown-up viewof suture insertion device 100 at threading notch 116. A center portionof a suture 36 can be looped into the threading notch 116 and attachedto or hooked onto the end of insertion shaft 108. Insertion shaft 108can then pull suture 36 through piercing shaft 104 for insertion into apatient's soft palate 22 and/or uvula 24. Since the center portion ofthe suture 36 will be the first portion of the suture to contact andenter the patient's soft palate 22 and/or uvula 24 upon deployment ofthe insertion shaft 108 out of the piercing shaft 104, the centerportion of the suture 36 is preferably clear (no barbs), which allowsthe center portion of the suture 36 to be more easily inserted into thesoft palate 22.

Once the suture 36 is attached to the end of insertion shaft 108,insertion shaft 108 can be moved to a second, intermediate configurationwherein insertion shaft 108 is pushed towards the front of piercingshaft 104 but does not extend past the piercing end 112 of piercingshaft 104. In the illustrated embodiment, suture release button 106 canbe used to move insertion shaft from the first position to the secondposition. Alternatively, insertion shaft adjustment 110 can be used tomove insertion shaft 108 from the first position to the second position.FIG. 20 shows a cross-sectional view with insertion shaft 108 in thesecond, intermediate position, and FIG. 21 shows a blown up view ofinsertion shaft 108 at the piercing end 112 of piercing shaft 104. Asthe insertion shaft 108 is pushed forward through piercing shaft 104,the attached suture 36 is also drawn through the piercing shaft 104.

FIG. 22 shows suture insertion device 100 being inserted into apatient's soft palate 22 at a high point at the midline of the softpalate 22. The placement of suture insertion device 100 should beverified. In the illustrated embodiment, piercing shaft 104 of sutureinsertion device 100 is inserted into the soft palate so that thepiercing end 112 extends to almost the tip 29 of the patient's uvula 24.In other embodiments, piercing shaft 104 of suture insertion device 100is inserted into the soft palate so that the piercing end 112 extends todifferent locations in the soft palate. The curve of piercing shaft 104is designed to approximately match the curvature of the patient's softpalate 22. Piercing shaft 104 can optionally include depth markings sothat the doctor performing the procedure can accurately determine howfar the piercing shaft 104 has been inserted into the patient's softpalate 22. In an example embodiment, piercing shaft 104 includes an 18mm straight portion and a curved portion with a 20 mm radius. In anotherexample embodiment, piercing shaft 104 includes a 9 mm straight portionand a curved portion with a 27 mm radius. In another example embodiment,piercing shaft 104 includes a curved portion with a 38 mm radius. Thoseof ordinary skill in the art will understand that the length andcurvature of piercing shaft 54 will vary according to the anatomic site.

Once the piercing shaft 104 has been inserted into the patient's softpalate 22, insertion shaft adjustment 110 can be moved to a third,deployed configuration wherein the insertion shaft 108 is pushed out ofpiercing shaft 104 and past the piercing end 112 of piercing shaft 104.FIG. 23 shows the third, deployed position. In an example embodiment,insertion shaft 108 is pushed out of the piercing shaft 104 and past thepiercing end 112 of piercing shaft 104 by pulling suture release button106. Alternatively, insertion shaft 108 can be pushed out of thepiercing shaft 104 and past the piercing end 112 of piercing shaft 104using insertion shaft adjustment 110. The release of insertion shaft 108from piercing shaft 104 also releases the attached suture 36 frompiercing shaft 104. The barbs 38 on suture 36 grab the patient's uvula24 and/or soft palate 22 and hold suture 36 in place as piercing shaft104 and insertion shaft 108 are withdrawn from the patient's soft palate22. FIG. 24 shows the release of a length of suture 36 as piercing shaft104 and insertion shaft 108 are withdrawn from the patient's soft palate22. Once the suture has been released into the patient's soft palate 22and/or uvula 24, insertion shaft 108 can be drawn back inside piercingshaft 108 in the intermediate position, or insertion shaft can remain inthe deployed position. The barbs 38 of suture 36 will hold suture 36within the patient's soft palate 22 and/or uvula 24. FIG. 24 shows theinsertion shaft 108 drawn back into the intermediate position aspiercing shaft 104 is withdrawn from the patient's soft palate 22.

FIG. 25 shows the patient's palate being elevated. Once piercing shaft104 has been withdrawn from the patient's soft palate 22, the patient'ssoft palate 22 and/or uvula 24 can be lifted, suspended and stiffened bypulling the suture 36 in a direction different from the insertiondirection of the piercing shaft 104. The pulling lifts the soft palate22 and/or uvula 24 as the barbs 38 of the suture 36 grab the patient'ssoft palate and/or uvula and pull the soft palate and/or uvula in thedirection of the pulling. The pulling also stiffens the soft palate 22and/or uvula 24 by compressing the soft palate and/or uvula into asmaller area. The barbs 38 suspend the soft palate 22 and/or uvula 24 inthe lifted and stiffened position once the doctor has appropriatelypositioned the soft palate and/or uvula. Proper placement of the suture36 can be verified by tugging and wiggling the suture. In an exampleembodiment, the center portion and/or another portion of suture 36 caninclude a sealing element so that the patient's soft palate 22 and/oruvula 24 will not be released from suture 36 over time. In oneembodiment, the sealing element can be a tissue sealant to secure or fixthe cut end of the suture and achieve long term lifting of the palate.In another embodiment, the sealing element can be a knot or clip tosecure or fix the cut end of the suture and achieve long term lifting ofthe palate. In yet another example embodiment, the suture 36 can beinserted into the patient's soft palate 22 and uvula 24 using thetriangular approach described above.

FIG. 26 illustrates yet another example embodiment of a suture insertiondevice 150 according to the present disclosure. In an exampleembodiment, suture insertion device 150 includes a main body 151, ahandle 152, a piercing shaft 154, a suture release button 156, and aninsertion shaft 158. Piercing shaft 154 includes a piercing end 160 witha sharp tip that allows piercing shaft 154 to be inserted into apatient's soft palate 22. In an example embodiment, piercing shaft 154is a cannula and tapers toward the piercing end 160, and insertion shaft158 is moveable within the cannula. In another example embodiment,piercing shaft 154 is about 36 mm in length, with the percutaneous endbeing 18 mm in length. Once inserted into the soft palate 22, insertionshaft 158 can be deployed from piercing shaft 154 so as to deploy alength of a suture 36. Because piecing end 150 pierces a patient's skin,suture insertion device 150 is preferably a disposable, single-usedevice that can be discarded after a single procedure so as not tospread infection amongst patients.

FIGS. 26 to 30 demonstrate an example method of using suture insertiondevice 150 to lift, suspend and stiffen a patient's soft palate 22 toopen the patient's airways. Preferably, suture insertion device 150 isnot preloaded with a suture 36. Instead, suture insertion device 150 canbe loaded with any type of suture 36 that a doctor chooses to best treata specific patient.

FIG. 26 shows suture insertion device 150 in a first, loadingconfiguration. In the loading configuration, insertion shaft 158 is in aloading position such that insertion shaft 158 is located withinpiercing shaft 154 but does not extend past threading notch 162 ofpiercing shaft 154. A center portion of a suture 36 can be looped intothreading notch 162. Since the center portion of the suture 36 will bethe first portion of the suture to contact and enter the patient's softpalate 22 and/or uvula 24 upon deployment of the insertion shaft 158 outof the piercing shaft 154, the center portion of the suture 36 ispreferably clear (no barbs), which allows the center portion of thesuture to be more easily inserted into the soft palate.

FIGS. 27 and 28 illustrate a blown-up view and a cross sectional view,respectively, of piercing shaft 154 after a suture 36 has been loopedinto threading notch 162. At this stage, insertion shaft 158 remains inthe loading position and does not contact suture 36. As illustrated inFIG. 28, the outer portion of piercing shaft 154 includes twosuture-retaining grooves 164. While suture insertion device 150 is inthe loading configuration, suture 36 can be looped over threading notch162 and threaded through the two suture-retaining grooves 164. Thesuture-retaining grooves 164 allow the suture 36 to remain outsidepiercing shaft 154 so that piercing shaft 154 can be inserted into apatient's soft palate 22 without the barbs 38 of the suture 36 grabbingthe patient's soft palate 22 until the doctor performing the procedurereleases the suture 36 from piercing shaft 154. FIGS. 27 and 28 show thesuture 36 after the suture has been looped over threading notch 162 andthreaded through the two suture-retaining grooves 164.

FIG. 29 shows suture insertion device 150 being inserted into thepatient's soft palate 22 at a high point at the midline of the softpalate 22. The placement of suture insertion device 150 should beverified. In the illustrated embodiment, piercing shaft 154 of sutureinsertion device 150 is inserted into the soft palate 22 so that thepiercing end 160 extends to almost the tip 29 of the patient's uvula 24.In other embodiments, piercing shaft 154 of suture insertion device 150can be inserted into the soft palate 22 so that the piercing end 160extends to different locations in the soft palate. The curve of piercingshaft 154 is designed to approximately match the curvature of thepatient's soft palate 22. The piercing shaft 154 can optionally includedepth markings so that the doctor performing the procedure canaccurately determine how far the piercing shaft 154 has been insertedinto the patient's soft palate. In an example embodiment, piercing shaft154 includes an 18 mm straight portion and a curved portion with a 20 mmradius. In another example embodiment, piercing shaft 154 includes a 9mm straight portion and a curved portion with a 27 mm radius. In anotherexample embodiment, piercing shaft 154 includes a curved portion with a38 mm radius. Those of ordinary skill in the art will understand thatthe length and curvature of piercing shaft 54 will vary according to theanatomic site.

Once the piercing shaft 154 has been inserted into the patient's softpalate 22 and/or uvula 24, suture release button 156 can be pressed sothat insertion shaft 158 moves through threading notch 162 and out ofpiercing shaft 154. As insertion shaft 158 moves through threading notch162, insertion shaft 158 forces suture 36 out of threading notch 162 sothat the barbs 38 of suture 36 move out of suture-retaining grooves 164and grab the patient's soft palate 22 and/or uvula 24. The barbs 38 onsuture 36 grab the patient's soft palate 22 and/or uvula 24 and holdsuture 36 in place as piercing shaft 154 and insertion shaft 158 arewithdrawn from the patient's soft palate 22. FIG. 30 shows the releaseof a length of suture 36 as piercing shaft 154 is withdrawn from thepatient's soft palate 22. Once piercing shaft 154 has been withdrawnfrom the patient's soft palate, the patient's soft palate 22 and/oruvula 24 can be lifted, suspended and stiffened by pulling the suture 36in a direction different from the insertion direction of the piercingshaft 154. The pulling lifts the soft palate 22 and/or uvula 24 as thebarbs of the suture 36 grab the patient's soft palate and/or uvula andpull the soft palate and/or uvula in the direction of the pulling. Thepulling also stiffens the soft palate 22 and/or uvula 24 by compressingthe soft palate and/or uvula into a smaller area. The barbs 38 suspendthe soft palate 22 and/or uvula 24 in the lifted and stiffened positiononce the doctor has appropriately positioned the soft palate and/oruvula. Proper placement of the suture 36 can be verified by tugging andwiggling the suture. In an example embodiment, the center portion and/oranother portion of suture 36 can include a sealing element so that thepatient's soft palate 22 and/or uvula 24 will not be released over time.In one embodiment, the sealing element can be a tissue sealant to secureor fix the cut end of the suture and achieve long term lifting of thepalate. In another embodiment, the sealing element can be a knot or clipto secure or fix the cut end of the suture and achieve long term liftingof the palate. In yet another example embodiment, the suture 36 can beinserted into the patient's soft palate 22 and uvula 24 using thetriangular approach described above.

FIGS. 31 and 32 illustrate yet another example embodiment of a sutureinsertion device 200 according to the present disclosure. In an exampleembodiment, suture insertion device 200 includes a main body 202, handle204, a piercing shaft 206, a clamp 208, and a twisting device 210.Piercing shaft 206 includes a threading notch 212 and a piercing end 214with a sharp tip that allows piercing shaft 206 to be inserted into apatient's soft palate 22. Because piecing end 214 pierces a patient'sskin, suture insertion device 200 is preferably a disposable, single-usedevice that can be discarded after a single procedure so as not tospread infection amongst patients.

FIGS. 31 to 38 demonstrate an example method of using suture insertiondevice 200 to lift, suspend and stiffen a patient's soft palate and/oruvula to open the patient's airways. Preferably, suture insertion device200 is not preloaded with a suture. Instead, suture insertion device canbe loaded with any type of suture that a doctor chooses to best treat aspecific patient.

FIG. 31 shows suture insertion device 200 in a first, loadingconfiguration. While the suture insertion device 200 is in the loadingconfiguration, a suture 36 can be looped over threading notch 212, asshown in FIG. 33. In the illustrated embodiment, suture 36 remainsoutside of piercing shaft 206. Since the center portion of the suture 36will be the first portion of the suture to contact and enter thepatient's soft palate 22 and/or uvula 24, the center portion of thesuture 36 is preferably clear (no barbs), which allows the centerportion of the suture to be more easily inserted into the soft palate.

Referring now to FIG. 34, clamp 208 can be released to an open positionso that after being looped over threading notch 212, suture 36 can bethreaded through an aperture 218 in the bottom portion 220 of clamp 208and pulled through twisting device 210. In an example embodiment, suture36 can be substantially taught between threading notch 212 and twistingdevice 210. The doctor performing the procedure can adjust the suture 36as needed. Once pulled through twisting device 210, suture 36 can betwisted by turning twisting device 210. In the illustrated embodiment,twisting device 210 is a twisting knob, but those of ordinary skill inthe art will recognize other ways to twist suture 36 before insertioninto a patient's soft palate 22 and/or uvula 24. Twisting suture 36allows suture 36 to be more easily inserted into a patient's soft palate22. Twisting suture 36 also creates barbs in multiple directions to grabthe patient's soft palate, doubles the strength of the suture 36, andcreates less slipping as the suture 36 pulls on the patient's softpalate 22 and/or uvula 24. Before twisting suture 36, the ends of suture36 attached to twisting device 210 can be cut to prevent wrapping andbinding as suture 36 is twisted. FIG. 35 illustrates suture insertiondevice 200 after suture 36 has been cut, and FIG. 36 illustrates sutureinsertion device 200 after the suture 36 has been twisted.

Once the suture 36 has been twisted, clamp 208 can be clamped to aclosed position, as illustrated in FIG. 37, by pulling down on the upperportion 222 with a thumb. Clamping clamp 208 in the closed positionpulls suture 36 closer to piercing shaft 206 for easier insertion into apatient's soft palate 22. Clamp 208 can include protrusions 224 thatmate with apertures 226 in main body 202 and/or apertures 228 that matewith protrusions 230 in main body 202. Once clamped, suture 36 can becut again at an intermediate portion 232 to release suture 36 fromattachment to twisting device 210.

FIG. 38 shows a suture 36 ready for insertion into a patient's softpalate 22 and/or uvula 34 after being cut and released from twistingdevice 210. At this stage, piercing shaft 206 of suture insertion device200 can be inserted into a patient's soft palate 22 at a high point atthe midline of the soft palate 22. The placement of suture insertiondevice 200 should be verified. Piercing shaft 206 of suture insertiondevice 200 can be inserted into the soft palate 22 so that the piercingend 214 extends to almost the tip 29 of the patient's uvula 24. Piercingshaft 206 of suture insertion device 200 can also be inserted into thesoft palate so that the piercing end 214 extends to different locationsin the soft palate 22. The curve of piercing shaft 206 is designed toapproximately match the curvature of the patient's soft palate 22.Piercing shaft 206 can optionally include depth markings so that thedoctor performing the procedure can accurately determine how far thepiercing shaft 206 has been inserted into the patient's soft palate. Inan example embodiment, piercing shaft 206 includes an 18 mm straightportion and a curved portion with a 20 mm radius. In another exampleembodiment, piercing shaft 206 includes a 9 mm straight portion and acurved portion with a 27 mm radius. In another example embodiment,piercing shaft 206 includes a curved portion with a 38 mm radius. Thoseof ordinary skill in the art will understand that the length andcurvature of piercing shaft 206 will vary according to the anatomicsite.

Once the piercing shaft 206 has been inserted into the patient's softpalate 22, clamp 208 can again be released to the open position, whichreleases suture 36 from clamp 208 so that piercing shaft 206 can bewithdrawn from the patient's soft palate 22 without withdrawing suture36, the barbs 38 of which will grab the tissue in the patient's softpalate. Once piercing shaft 206 has been withdrawn from the patient'ssoft palate 22, the patient's soft palate 22 and/or uvula 24 can belifted and stiffened by pulling the suture 36 in a direction differentfrom the insertion direction of the piercing shaft 206. The pullinglifts the soft palate 22 and/or uvula 24 as the barbs of the suture 36grab the patient's soft palate and/or uvula and pull the soft palateand/or uvula in the direction of the pulling. The pulling also stiffensthe soft palate 22 and/or uvula 24 by compressing the soft palate and/oruvula into a smaller area. The barbs 38 suspend the soft palate 22and/or uvula 24 in the lifted and stiffened position once the doctor hasappropriately positioned the soft palate and/or uvula. Proper placementof the suture 36 can be verified by tugging and wiggling the suture. Inan example embodiment, the center portion and/or another portion ofsuture 36 can include a sealing element so that the patient's softpalate 22 and/or uvula 24 will not be released over time. In oneembodiment, the sealing element can be a tissue sealant to secure or fixthe cut end of the suture and achieve long term lifting of the palate.In another embodiment, the sealing element can be a knot or clip tosecure or fix the cut end of the suture and achieve long term lifting ofthe palate. In yet another example embodiment, the suture 36 can beinserted into the patient's soft palate 22 and uvula 24 using thetriangular approach described above.

FIG. 39 illustrates yet another example embodiment of a suture insertiondevice 300 according to the present disclosure. In an exampleembodiment, suture insertion device 300 includes a main body 302, ahandle 304, a piercing shaft 306, a clamp 308, and a twisting device310. Piercing shaft 306 includes a threading notch 312 and a piercingend 314 with a sharp tip that allows piercing shaft 306 to be insertedinto a patient's soft palate 22. Because piecing end 314 pierces apatient's skin, suture insertion device 300 is preferably a disposable,single-use device that can be discarded after a single procedure so asnot to spread infection amongst patients.

FIGS. 40 to 42 demonstrate an example method of using suture insertiondevice 300 to lift, suspend and stiffen a patient's soft palate and/oruvula to open the patient's airways. Preferably, suture insertion device300 is not preloaded with a suture. Instead, suture insertion device 300can be loaded with any type of suture that a doctor chooses to besttreat a specific patient.

FIG. 40 shows suture insertion device 300 in a first, loadingconfiguration. While the suture insertion device 300 is in the loadingconfiguration, a suture 36 can be looped over threading notch 312. Inthe illustrated embodiment, suture 36 remains outside of piercing shaft306. Since the center portion of the suture 36 will be the first portionof the suture to contact and enter the patient's soft palate 22 and/oruvula 24, the center portion of the suture 36 is preferably clear (nobarbs), which allows the center portion of the suture to be more easilyinserted into the soft palate.

In FIG. 40, clamp 308 is shown to be released to an open position sothat after being looped over threading notch 312, suture 36 can bethreaded between clamp 308 and main body 302 and pulled through a sutureretaining element 320 in twisting device 310. In an example embodiment,suture 36 can be substantially taught between threading notch 312 andtwisting device 310. The doctor performing the procedure can adjust thesuture 36 as needed. Once pulled through twisting device 310, suture 36can be twisted by turning twisting device 310, as shown in FIG. 41.Twisting suture 36 allows suture 36 to be more easily inserted into apatient's soft palate 22. Twisting suture 36 also creates barbs inmultiple directions to grab the patient's soft palate, doubles thestrength of the suture 36, and creates less slipping as the suture 36pulls on the patient's soft palate 22 and/or uvula 24.

Once the suture 36 has been twisted, clamp 308 can be clamped to aclosed position, as illustrated in FIG. 42, by pulling down on the upperportion 322 of clamp 308 with a thumb. Clamping clamp 308 in the closedposition pulls suture 36 closer to piercing shaft 306 for easierinsertion into a patient's soft palate 22. Clamp 308 can includeprotrusions that mate with apertures in main body 202 and/or aperturesthat mate with protrusions in main body 202. Once clamped, suture 36 canbe cut again at an intermediate portion 322 to release suture 36 fromattachment to twisting device 310.

FIG. 42 shows a suture 36 ready for insertion into a patient's softpalate 22 and/or uvula 34 after being cut and released from twistingdevice 310. At this stage, piercing shaft 306 of suture insertion device300 can be inserted into a patient's soft palate 22 at a high point atthe midline of the soft palate 22. The placement of suture insertiondevice 300 should be verified. Piercing shaft 306 of suture insertiondevice 300 can be inserted into the soft palate 22 so that the piercingend 314 extends to almost the tip 29 of the patient's uvula 24. Piercingshaft 306 of suture insertion device 200 can also be inserted into thesoft palate so that the piercing end 314 extends to different locationsin the soft palate 22. The curve of piercing shaft 306 is designed toapproximately match the curvature of the patient's soft palate 22.Piercing shaft 306 can optionally include depth markings so that thedoctor performing the procedure can accurately determine how far thepiercing shaft 306 has been inserted into the patient's soft palate. Inan example embodiment, piercing shaft 306 includes an 18 mm straightportion and a curved portion with a 20 mm radius. In another exampleembodiment, piercing shaft 306 includes a 9 mm straight portion and acurved portion with a 27 mm radius. In another example embodiment,piercing shaft 306 includes a curved portion with a 38 mm radius. Thoseof ordinary skill in the art will understand that the length andcurvature of piercing shaft 306 will vary according to the anatomicsite.

Once the piercing shaft 306 has been inserted into the patient's softpalate 22, clamp 308 can again be released to the open position, whichreleases suture 36 from clamp 308 so that piercing shaft 306 can bewithdrawn from the patient's soft palate 22 without withdrawing suture36, the barbs 38 of which will grab the tissue in the patient's softpalate. Once piercing shaft 306 has been withdrawn from the patient'ssoft palate 22, the patient's soft palate 22 and/or uvula 24 can belifted, suspended and stiffened by pulling the suture 36 in a directiondifferent from the insertion direction of the piercing shaft 306. Thepulling lifts the soft palate 22 and/or uvula 24 as the barbs of thesuture 36 grab the patient's soft palate and/or uvula and pull the softpalate and/or uvula in the direction of the pulling. The pulling alsostiffens the soft palate 22 and/or uvula 24 by compressing the softpalate and/or uvula into a smaller area. The barbs 38 suspend the softpalate 22 and/or uvula 24 in the lifted and stiffened position once thedoctor has appropriately positioned the soft palate and/or uvula. Properplacement of the suture 36 can be verified by tugging and wiggling thesuture. In an example embodiment, the center portion and/or anotherportion of suture 36 can include a sealing element so that the patient'ssoft palate 22 and/or uvula 24 will not be released over time. In oneembodiment, the sealing element can be a tissue sealant to secure or fixthe cut end of the suture and achieve long term lifting of the palate.In another embodiment, the sealing element can be a knot or clip tosecure or fix the cut end of the suture and achieve long term lifting ofthe palate. In yet another example embodiment, the suture 36 can beinserted into the patient's soft palate 22 and uvula 24 using thetriangular approach described above.

The methods and apparatuses disclosed herein are advantageous becausethey preserve the native palate anatomy and its function. The uvulalubricates and sweeps the posterior pharyngeal wall during swallowingand clears it from stagnant secretions. By simply lifting, suspendingand stiffening the soft palate and/or uvula, instead of trimming thesoft palate and/or uvula, the disclosed methods and apparatuses do notaffect the function of the uvula, only the shape of the uvula. In anexample embodiment, the methods and apparatuses disclosed herein canturn a low frequency-high amplitude (Velum Type) snoring from anelongated uvula into a high frequency-low amplitude sound.

Modifications in addition to those described above may be made to thestructures and techniques described herein without departing from thespirit and scope of the disclosure. Accordingly, although specificembodiments have been described, these are examples only and are notlimiting on the scope of the disclosure.

EXAMPLES

The following non-limiting examples present evidence supporting theeffectiveness of the methods and apparatuses described herein.Specifically, these examples show that the methods and apparatusesdescribed herein are effective to lift, suspend and stiffen a patient'stissue, more specifically a patient's soft palate.

Example 1: Patient 1

In a first example, Patient 1 was an adult male. Size 0 barbed sutureswere inserted into Patient 1's soft palate using a needle. The sutureswere inserted into Patient 1's soft palate using both the straightdown-and-up approach and triangular approach described above. Thelengths of the test sutures were approximately the length of thepatient's palate. With both approaches it was observed that the sutureseffectively lifted, suspended and stiffened Patient 1's soft palate anduvula. The sutures were removed from Patient 1 after the test wascomplete.

Example 2: Patient 2

In a second example, Patient 2 was an adult male. Size 1 barbed sutureswere inserted into Patient 2's soft palate using a needle. The sutureswere inserted into Patient 2's soft palate using both the straightdown-and-up approach and triangular approach described above. Thelengths of the test sutures were approximately the length of thepatient's palate. With both approaches it was observed that the sutureseffectively lifted, suspended and stiffened Patient 2's soft palate anduvula. The sutures were removed from Patient 2 after the test wascomplete.

Example 3: Patient 3

In a third example, Patient 3 was an adult female. Size 2 barbed sutureswere inserted into Patient 3's soft palate using a needle. The sutureswere inserted into Patient 3's soft palate using both the straightdown-and-up approach and triangular approach described above. Thelengths of the test sutures were approximately the length of thepatient's palate. With both approaches it was observed that the sutureseffectively lifted, suspended and stiffened Patient 3's soft palate anduvula. The sutures were removed from Patient 3 after the test wascomplete.

Example 4: Meat

In a fourth example, a suture insertion device according to the presentdisclosure was tested on several samples of meat to determine theeffectiveness of the device in lifting and suspending with a singlesuture. 15 gram, 30 gram and 150 gram meat samples were tested todetermine whether a single suture inserted with the suture insertiondevice using the straight down-and-up approach described above couldeffectively lift and suspend the samples. These samples were chosenbecause they were heavier than a typical patient's soft palate anduvula.

The samples were first tested with a non-barbed size 0 nylon sutureusing the straight down-and-up approach described above. The non-barbedsize 0 nylon sutures could not lift and suspend the samples of meat.Instead, the non-barbed size 0 nylon sutures were immediately pulled outof the samples.

The 15 gram, 30 gram and 150 gram meat samples were then tested with abarbed size 2 suture using the straight down-and-up approach describedabove. It was observed that using the suture insertion device with thebarbed size 2 suture effectively lifted, suspended and stiffened each ofthe samples for at least 5 minutes until the test was concluded.

Additional Aspects of the Present Disclosure

Aspects of the subject matter described herein may be useful alone or incombination with any one or more of the other aspect described herein.Without limiting the foregoing description, in a first aspect of thepresent disclosure, a method of lifting and stiffening a patient'stissue includes inserting at least one suture into the patient's tissuein a first direction, pulling the suture in a second direction so as tolift and suspend the tissue in a lifted position and stiffen the tissuein the lifted position, and cutting the suture so that the tissueremains in the lifted position.

In accordance with a second aspect of the present disclosure, which maybe used in combination with any other aspect or combination of aspectslisted herein, the patient's tissue is the patient's soft palate.

In accordance with a third aspect of the present disclosure, which maybe used in combination with any other aspect or combination of aspectslisted herein, inserting the at least one suture into the patient's softpalate includes inserting the at least one suture proximal to a midlinepatient's soft palate.

In accordance with a fourth aspect of the present disclosure, which maybe used in combination with any other aspect or combination of aspectslisted herein, inserting the at least one suture into the patient's softpalate includes inserting the at least one suture into the patient'ssoft palate and uvula.

In accordance with a fifth aspect of the present disclosure, which maybe used in combination with any other aspect or combination of aspectslisted herein, pulling the suture includes lifting, suspending andstiffening the patient's uvula.

In accordance with a sixth aspect of the present disclosure, which maybe used in combination with any other aspect or combination of aspectslisted herein, the method includes enabling the suture to dissolve inthe patient's soft palate.

In accordance with a seventh aspect of the present disclosure, which maybe used in combination with any other aspect or combination of aspectslisted herein, the method includes anesthetizing the patient's softpalate.

In accordance with an eighth aspect of the present disclosure, which maybe used in combination with any other aspect or combination of aspectslisted herein, inserting the at least one suture into the patient's softpalate includes inserting the at least one suture with a needle.

In accordance with a ninth aspect of the present disclosure, which maybe used in combination with any other aspect or combination of aspectslisted herein, inserting the at least one suture into the patient's softpalate includes inserting the at least one suture with a sutureinsertion device, and further including releasing the suturecontinuously from the suture insertion device.

In accordance with a tenth aspect of the present disclosure, which maybe used in combination with any other aspect or combination of aspectslisted herein, inserting the at least one suture into the patient's softpalate includes inserting the at least one suture with a sutureinsertion device, and further including releasing the suture from thesuture insertion device in discrete increments.

In accordance with an eleventh aspect of the present disclosure, whichmay be used in combination with any other aspect or combination ofaspects listed herein, a method of lifting and stiffening a patient'stissue includes loading a suture onto a piercing shaft of a sutureinsertion device, inserting the piercing shaft into the patient's tissuein a first direction, releasing the suture from the piercing shaft,withdrawing the piercing shaft from the patient's tissue, and pullingthe suture in a second direction so as to lift, suspend and stiffen thetissue.

In accordance with a twelfth aspect of the present disclosure, which maybe used in combination with any other aspect or combination of aspectslisted herein, inserting the piercing shaft into the patient's tissueincludes inserting the piercing shaft into the patient's soft palate.

In accordance with a thirteenth aspect of the present disclosure, whichmay be used in combination with any other aspect or combination ofaspects listed herein, loading the suture onto the piercing shaftincludes threading the suture through a threading notch in the piercingshaft.

In accordance with a fourteenth aspect of the present disclosure, whichmay be used in combination with any other aspect or combination ofaspects listed herein, loading the suture onto the piercing shaftincludes clamping the suture to the suture insertion device.

In accordance with a fifteenth aspect of the present disclosure, whichmay be used in combination with any other aspect or combination ofaspects listed herein, releasing the suture from the piercing shaftincludes unclamping the suture.

In accordance with a sixteenth aspect of the present disclosure, whichmay be used in combination with any other aspect or combination ofaspects listed herein, loading the suture onto the piercing shaftincludes twisting the suture.

In accordance with a seventh aspect of the present disclosure, which maybe used in combination with any other aspect or combination of aspectslisted herein, loading the suture onto the piercing shaft includesattaching the suture to an insertion shaft within the piercing shaft.

In accordance with a eighteenth aspect of the present disclosure, whichmay be used in combination with any other aspect or combination ofaspects listed herein, loading the suture onto the piecing shaftincludes pulling the suture through a first portion of the piecingshaft.

In accordance with a nineteenth aspect of the present disclosure, whichmay be used in combination with any other aspect or combination ofaspects listed herein, releasing the suture from the piercing shaftincludes pushing the suture through a second portion of the piercingshaft.

In accordance with a twentieth aspect of the present disclosure, whichmay be used in combination with any other aspect or combination ofaspects listed herein, inserting the piercing shaft into the patient'ssoft palate includes inserting a piercing end of the piercing shaft sothat the piercing end extends to almost a tip of a uvula.

In accordance with a twenty-first aspect of the present disclosure,which may be used in combination with any other aspect or combination ofaspects listed herein, the method includes applying a sealing element tothe suture.

In accordance with a twenty-second aspect of the present disclosure,which may be used in combination with any other aspect or combination ofaspects listed herein, a suture insertion device includes a body, and apiercing shaft connected to the body, the piercing shaft including apiercing end, the piercing shaft configured to pierce a patient's tissuewith the piercing end and insert a suture into the patient's tissue in afirst direction, wherein the piercing shaft is further configured torelease the suture into the patient's tissue such that the suture can bepulled in a second direction to lift, suspend and stiffen the patient'stissue once the piercing shaft is removed from the patient's tissue.

In accordance with a twenty-third aspect of the present disclosure,which may be used in combination with any other aspect or combination ofaspects listed herein, the patient's tissue is the patient's softpalate.

In accordance with a twenty-fourth aspect of the present disclosure,which may be used in combination with any other aspect or combination ofaspects listed herein, the piercing shaft is a cannula.

In accordance with a twenty-fifth aspect of the present disclosure,which may be used in combination with any other aspect or combination ofaspects listed herein, the piercing shaft includes a threading notch toreceive the suture.

In accordance with a twenty-sixth aspect of the present disclosure,which may be used in combination with any other aspect or combination ofaspects listed herein, the threading notch is located proximal to thepiercing end.

In accordance with a twenty-seventh aspect of the present disclosure,which may be used in combination with any other aspect or combination ofaspects listed herein, the threading notch is located distal to thepiercing end.

In accordance with a twenty-eighth aspect of the present disclosure,which may be used in combination with any other aspect or combination ofaspects listed herein, the suture insertion device includes an insertionshaft, the insertion shaft configured to release the suture from thepiercing shaft.

In accordance with a twenty-ninth aspect of the present disclosure,which may be used in combination with any other aspect or combination ofaspects listed herein, the threading notch is located distal to thepiercing end and the insertion shaft pulls the suture through thepiercing shaft.

In accordance with a thirtieth aspect of the present disclosure, whichmay be used in combination with any other aspect or combination ofaspects listed herein, the threading notch is located proximal to thepiercing end and the insertion shaft pushes the suture off of thepiercing shaft.

In accordance with a thirty-first aspect of the present disclosure,which may be used in combination with any other aspect or combination ofaspects listed herein, the suture insertion device includes a clampconfigure to clamp the suture to the body for prior to the piercingshaft being inserted into the patient's tissue and release the suturefrom the body after the piercing shaft is inserted into the patient'stissue.

In accordance with a thirty-second aspect of the present disclosure,which may be used in combination with any other aspect or combination ofaspects listed herein, the suture insertion device includes a twistingdevice.

In accordance with a thirty-third aspect of the present disclosure,which may be used in combination with any other aspect or combination ofaspects listed herein, the suture insertion device includes a suturecutting device.

In accordance with a thirty-fourth aspect of the present disclosure,which may be used in combination with any other aspect or combination ofaspects listed herein, the piercing shaft is curved to match thecurvature of the patient's soft palate.

In accordance with a thirty-fifth aspect of the present disclosure,which may be used in combination with any other aspect or combination ofaspects listed herein, the piercing shaft includes depth markings.

In accordance with a thirty-sixth aspect of the present disclosure,which may be used in combination with any other aspect or combination ofaspects listed herein, the piercing shaft includes at least onesuture-retaining groove.

In accordance with a thirty-seventh aspect of the present disclosure,which may be used in combination with any other aspect or combination ofaspects listed herein, a suture insertion device includes a means forloading a suture, a means for inserting the suture into a patient'stissue in a first direction, and a means for releasing the suture sothat the suture can be pulled in a second direction different from thefirst direction so as to lift, suspend and stiffen the tissue.

In accordance with a thirty-eighth aspect of the present disclosure,which may be used in combination with any other aspect or combination ofaspects listed herein, the patient's tissue is the patient's softpalate.

In accordance with a thirty-ninth aspect of the present disclosure,which may be used in combination with any other aspect or combination ofaspects listed herein, the suture insertion device includes a cannula,wherein the means for loading the suture includes a means for pullingthe suture through the cannula.

In accordance with a fortieth aspect of the present disclosure, whichmay be used in combination with any other aspect or combination ofaspects listed herein, the means for loading the suture includes a meansfor clamping the suture.

In accordance with a forty-first aspect of the present disclosure, whichmay be used in combination with any other aspect or combination ofaspects listed herein, the means for loading the suture includes a meansfor twisting the suture.

In accordance with a forty-second aspect of the present disclosure,which may be used in combination with any other aspect or combination ofaspects listed herein, the suture insertion device includes a means fordetermining how deep the suture has been inserted into the patient'stissue.

In accordance with a forty-third aspect of the present disclosure, whichmay be used in combination with any other aspect or combination ofaspects listed herein, a suture insertion device includes a body, apiercing shaft connected to the body, the piercing shaft including acannula and a threading notch configured to receive a suture, and aninsertion shaft moveable within the cannula, the insertion shaftconfigured to release the suture from the piercing shaft.

In accordance with a forty-fourth aspect of the present disclosure,which may be used in combination with any other aspect or combination ofaspects listed herein, the patient's tissue is the patient's softpalate.

In accordance with a forty-fifth aspect of the present disclosure, whichmay be used in combination with any other aspect or combination ofaspects listed herein, the threading notch is located proximal to thepiercing end.

In accordance with a forty-sixth aspect of the present disclosure, whichmay be used in combination with any other aspect or combination ofaspects listed herein, the threading notch is located distal to thepiercing end.

In accordance with a forty-seventh aspect of the present disclosure,which may be used in combination with any other aspect or combination ofaspects listed herein, the insertion shaft pulls the suture through thepiercing shaft.

In accordance with a forty-eighth aspect of the present disclosure,which may be used in combination with any other aspect or combination ofaspects listed herein, the insertion shaft pushes the suture off of thepiercing shaft.

In accordance with a forty-ninth aspect of the present disclosure, whichmay be used in combination with any other aspect or combination ofaspects listed herein, the piercing shaft includes at least onesuture-retaining groove.

In accordance with a fiftieth aspect of the present disclosure, whichmay be used in combination with any other aspect or combination ofaspects listed herein, a suture insertion device includes a body, apiercing shaft connected to the body, the piercing shaft including athreading notch configured to receive a suture, and a clamp configuredto clamp the suture to the body when the piercing shaft is inserted intoa patient's tissue and to release the suture from the body when thepiercing shaft is withdrawn from the patient's tissue.

In accordance with a fifty-first aspect of the present disclosure, whichmay be used in combination with any other aspect or combination ofaspects listed herein, the patient's tissue is the patient's softpalate.

In accordance with a fifty-second aspect of the present disclosure,which may be used in combination with any other aspect or combination ofaspects listed herein, the suture insertion device includes a twistingdevice.

In accordance with a fifty-third aspect of the present disclosure, whichmay be used in combination with any other aspect or combination ofaspects listed herein, the suture can be threaded through an aperture inthe clamp and pulled through the twisting device.

In accordance with a fifty-fourth aspect of the present disclosure,which may be used in combination with any other aspect or combination ofaspects listed herein, the clamp includes protrusions that mate withapertures in the body.

In accordance with a fifty-fifth aspect of the present disclosure, whichmay be used in combination with any other aspect or combination ofaspects listed herein, the clamp includes apertures that mate withprotrusions in the body.

In accordance with a fifty-sixth aspect of the present disclosure, whichmay be used in combination with any other aspect or combination ofaspects listed herein, the clamp is operable between an open positionand a closed position.

In accordance with a fifty-seventh aspect of the present disclosure,which may be used in combination with any other aspect or combination ofaspects listed herein, the suture insertion device includes a suturecutting device.

In accordance with a fifty-eighth aspect of the present disclosure,which may be used in combination with any other aspect or combination ofaspects listed herein, the piercing shaft is curved to match thecurvature of the patient's soft palate.

In accordance with a fifty-ninth aspect of the present disclosure, whichmay be used in combination with any other aspect or combination ofaspects listed herein, the piercing shaft includes depth markings.

In accordance with a sixtieth aspect of the present disclosure, whichmay be used in combination with any other aspect or combination ofaspects listed herein, the piercing shaft includes at least onesuture-retaining groove.

1-60. (canceled) 61: A suture insertion device, comprising: a bodyconfigured to be gripped by a user; a shaft extending longitudinallyfrom the body, the shaft including an outer surface that extends to apiercing end, the outer surface including an indented notch; and asuture loaded into the indented notch for insertion into the patient'stissue, wherein the shaft is configured insert the suture into thepatient's tissue by: (i) piercing the patient's tissue with the piercingend at an insertion point into the patient's tissue; (ii) entering thepatient's tissue at the insertion point such that the indented notchpasses the insertion point into the patient's tissue; and (iii)withdrawing from the patient's tissue at the insertion point, leavingthe suture at least partially in the patient's tissue such that thesuture only protrudes from the patient's tissue at the insertion pointafter the shaft is withdrawn. 62: The suture insertion device of claim61, wherein the shaft includes a straight portion and curved portion,and wherein the curved portion is located proximal to the piercing endand the straight portion is located between the curved portion and thebody. 63: The suture insertion device of claim 61, wherein the bodyincludes a mechanism enabling the suture to be tightened against theshaft after the suture is loaded into the notch. 64: The sutureinsertion device of claim 61, wherein the suture is a barbed suture, andwherein the shaft includes at least one groove extending along alongitudinal length of the outer surface of the shaft between the notchand the body, the groove configured to prevent barbs from the suturefrom grabbing the patient's tissue as the shaft enters the patient'stissue at the insertion point. 65: The suture insertion device of claim61, wherein the shaft is directly connected to the body. 66: The sutureinsertion device of claim 61, wherein the suture includes a firstportion and a second portion, the first portion loaded into the indentednotch, the second portion attaching to the body to pull the firstportion against the shaft for insertion into the patient's tissue. 67:The suture insertion device of claim 61, wherein the suture includes afirst portion and a second portion, the first portion loaded into theindented notch, the second portion protruding from the patient's tissueat the insertion point after the shaft is withdrawn. 68: The sutureinsertion device of claim 61, wherein the suture is pre-loaded into theindented notch for implantation into the patient's tissue. 69: A methodof using the suture insertion device of claim 61 to implant the sutureinto the patient's tissue. 70: A suture insertion device, comprising: abody configured to be gripped by a user; a shaft including a straightportion extending longitudinally from the body and a curved portionextending from the straight portion to a piercing end; and a sutureloaded onto the curved portion for insertion into the patient's tissue,wherein the shaft is configured insert the suture into the patient'stissue by: (i) piercing the patient's tissue with the piercing end at aninsertion point into the patient's tissue; (ii) entering the patient'stissue at the insertion point such that the suture is at least partiallyinserted into the patient's tissue; and (iii) withdrawing from thepatient's tissue at the insertion point, leaving the suture at leastpartially in the patient's tissue such that the suture only protrudesfrom the patient's tissue at the insertion point after the shaft iswithdrawn. 71: The suture insertion device of claim 70, wherein the bodyincludes a mechanism enabling the suture to be tightened against theshaft after the suture is loaded onto the curved portion. 72: The sutureinsertion device of claim 70, wherein the suture is a barbed suture,wherein the shaft includes at least one groove extending along alongitudinal length of the shaft, the groove configured to prevent barbsfrom the suture from grabbing the patient's tissue as the shaft entersthe patient's tissue at the insertion point. 73: The suture insertiondevice of claim 70, wherein the shaft is directly connected to the body.74: The suture insertion device of claim 70, wherein the suture includesa first portion and a second portion, the first portion loaded onto thecurved portion, the second portion attaching to the body to pull thefirst portion against the shaft for insertion into the patient's tissue.75: The suture insertion device of claim 70, wherein the suture includesa first portion and a second portion, the first portion loaded onto thecurved portion, the second portion protruding from the patient's tissueat the insertion point after the shaft is withdrawn. 76: The sutureinsertion device of claim 70, wherein the suture is pre-loaded into theindented notch for implantation into the patient's tissue. 77: A methodof using the suture insertion device of claim 70 to implant the sutureinto the patient's tissue. 78: A suture insertion device, comprising: abody configured to be gripped by a user; and a shaft including an outersurface extending longitudinally from the body to a piercing end, theouter surface including an indented notch proximal to the piercing end,the notch configured to receive a barbed suture, and an indented grooveextending longitudinally along at least a portion of the shaft betweenthe notch and the body, the indented groove configured to prevent barbsfrom the barbed suture from grabbing a patient's tissue as the shaftenters the patient's tissue. 79: The suture insertion device of claim78, wherein the shaft is configured to: (i) enter the patient's tissueat an insertion point pierced by the piercing end; and (ii) leave thebarbed suture at least partially in the patient's tissue such that thebarbed suture only protrudes from the patient's tissue at the insertionpoint. 80: The suture insertion device of claim 78, wherein the shaftincludes a straight portion and curved portion, and wherein the curvedportion is located proximal to the piercing end and the straight portionis located between the curved portion and the body.